Monday, November 13, 2017

Promise Doctrine Zombie Watch

Pfizer Canada Inc v Apotex Inc 2017 FC 774 Brown J
2,436,668 / desvenlafaxine (ODV) / PRISTIQ / NOC

Bristol-Myers Squibb Canada Co v Apotex Inc 2017 FCA 190 [Dasatinib FCA] Gleason JA: Webb, Near JJA var’g 2017 FC 296 [Dasatinib FC] Manson J
            2,366,932 / 2,519,898 / dasatinib / SPRYCEL / NOC

The promise doctrine was abolished by the SCC in AstraZeneca 2017 SCC 36 (see here). Will it rise from the dead, in some other guise? So far, the indications are that it will not.

The issue was addressed by Brown J in Desvenlafaxine (blogged here on the obvious-to-try issue). In its post-hearing submissions directed AstraZeneca, Apotex submitted that the 668 Patent "overpromises" in violation of the requirements of subsection 27(3) of the Patent Act [355]. In particular [356], Apotex argued (emphasis added):

33. As noted above, in AstraZeneca, the Supreme Court directed that overpromising violates the require[ments] of subsection 27(3) of the Patent Act. An invention is subject matter that has demonstrated utility as of the filing date, or subject that matter that constitutes a sound prediction as of the filing date. The statements in the 668 patent to the effect that the compounds of the patent have the utilities (1)-(3) above were thus not 'correct and full' descriptions of the invention but rather were overpromises. As such, they ought to invalidate the 668 patent as a whole.

The argument turns on the SCC’s statement in AstraZeneca [45]-[46] (quoted at [362]):

[45] Supporters of the doctrine assert that the consequences of the Promise Doctrine play a key role in ensuring patentees do not "overpromise" in their patent applications. . . . The utility requirement should not be interpreted, however, as the Federal Courts have done, to address such concerns. Nonetheless, overpromising is a mischief.

[46] The scheme of the Act treats the mischief of overpromising in multiple ways.

The SCC noted [46] that these ways include the disclosure requirements of s. 27(3), overbreadth, and s 53, which provides that a patent is invalid where overpromising in a specification amounts to an omission or addition that is "willfully made for the purpose of misleading".

Does this mean that the promise doctrine is fundamentally sound, and the only error was to implement it through the utility requirement? The answer is no. As Brown J stated:

[360] If the Supreme Court intended to say, in effect, that the Promise Doctrine was not good law in terms of utility under s 2, but was good law in terms of patent specifications under subsection 27(3) it could have done so; it did not.

Moreover, the SCC identified specific functional defects of the promise doctrine – that it risks invalidating an otherwise useful invention [50], and that it impedes fulsome disclosure [51]. As Brown J pointed out, if the SCC removed the promise doctrine from the utility analysis, but functionally replicated it under another name, the “major underlying problem identified by the Supreme Court itself would remain” [363].

Consequently, Brown J rejected Apotex’s argument, agreeing with Pfizer that [361.5]:

Read purposively, the Court was referring to those extraordinary circumstances in which the statements in a patent prevent a skilled reader from understanding "the nature of the invention" or "how it is put into operation." These have always been (and remain) the core requirements of s. 27(3). . .

That is, “overpromising” as the term was used in AstraZeneca, refers to the types of defects that are already addressed by other aspects of the Act. The justifications that have been offered by supporters of the promise doctrine, do not in fact justify that doctrine, because, to the extent that they identify a proper goal of the patent system, those goals are already addressed by other aspects of the Act: see eg AstraZeneca [46]; Siebrasse, The False Doctrine of False Promise, (2013) 29(1) CIPR 3, 51-52; Siebrasse, Form and Function in the Law of Utility, (2015) 30(2) CIPR 109 (generally). The role that is unique to the promise doctrine, and which is not replicated by any other aspect of the Act, namely to protect the discretion of the Crown in the grant of patents, is not an aspect of our patent system: AstraZeneca [45]-[46], citing Siebrasse, The False Doctrine of False Promise, (2013) 29(1) CIPR 3.

Dasatinib FCA, the only FCA decision to deal with utility since AstraZeneca, is important for the guidance it provided regarding the scintilla standard, but Dasatinib FCA also faced a zombie promise doctrine. The SCC in AstraZeneca [54] held that the first step in the utility analysis is to “identify the subject-matter of the invention claimed in the patent.” In Dasatinib, the claim at issue was to the compound dasatinib as such [22] (see here). Apotex argued that the subject-matter of claim 27 of the 932 patent was the potential therapeutic uses for dasatinib [37]. While the FCA did not say so expressly, this seems to have been an attempt by Apotex to raise the promise doctrine in the context of the utility itself; if the therapeutic uses, set out only in the disclosure, were considered to be the subject-matter of the invention, we would be back to the problem of assessing utility against the statements made in the disclosure. The FCA rejected this argument, saying “the subject-matter of claim 27 is merely the compound, dasatinib, itself” [37].

So, both of the post-AstraZeneca decisions to address utility have squarely rejected any attempt to resurrect the promise doctrine. My sense is that the prior to AstraZeneca, the Federal Courts were committed to the promise doctrine as being established law, but not as a matter of patent policy (see eg here), and consequently they have fully embraced the SCC’s repudiation of the doctrine. This contrasts with the reception of the Viagra 2012 SCC 60 decision, which could have been read as undermining the basic principle that claims stand and fall independently: see Siebrasse, The Duty to Disclose "The Invention" (2013) 25 IPJ 269. The courts have rejected this reading (rightly, in my view), and instead interpreted the decision as standing for the principle that a patentee cannot attempt to “game the system”: see here. It is early days yet, but I am nonetheless reasonably confident that we will not see the promise doctrine re-emerge under another guise.

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